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A Pilot Study of TRV130 for the Treatment of Fracture Pain

Primary Purpose

Pain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TRV130

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Long bone, Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-65 years, inclusive
Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
Able to understand and comply with study procedures and requirements, and provide written informed consent

Exclusion Criteria:

Significant concomitant head, chest, or abdominal trauma
Multiple extremity trauma
Open fracture
Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs

Sites / Locations

Trevena, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRV130

Arm Description

Drug: TRV130

Outcomes

Primary Outcome Measures

Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Secondary Outcome Measures

Time Weighted Average Change in NPRS

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Time to First NPRS <= 3

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Safety Assessments

Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.

Full Information

NCT ID

NCT02520297

First Posted

August 7, 2015

Last Updated

August 18, 2020

Sponsor

Trevena Inc.

Collaborators

Kestrel Biologic

1. Study Identification

Unique Protocol Identification Number

NCT02520297

Brief Title

A Pilot Study of TRV130 for the Treatment of Fracture Pain

Official Title

A Phase 2, Open-label Pilot Study of TRV130 for the Treatment of Moderate to Severe Acute Pain Associated With Long Bone Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Study Start Date

October 20, 2015 (Actual)

Primary Completion Date

October 23, 2015 (Actual)

Study Completion Date

October 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trevena Inc.

Collaborators

Kestrel Biologic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.

Detailed Description

This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Pain, Long bone, Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRV130

Arm Type

Experimental

Arm Description

Drug: TRV130

Intervention Type

Drug

Intervention Name(s)

TRV130

Intervention Description

Drug

Primary Outcome Measure Information:

Title

Proportion of Patients Achieving Clinical Response, Defined as Achieving a NPRS <= 3, Without Requiring Rescue Pain Medication.

Description

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Time Frame

3-hours

Secondary Outcome Measure Information:

Title

Time Weighted Average Change in NPRS

Description

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Time Frame

From baseline to 30 minutes, to 1 hour, to 2 hours and to 3 hours

Title

Time to First NPRS <= 3

Description

Pain intensity will be evaluated using an 11-point numeric pain rating scale administered over 3 hours

Time Frame

3-hours

Title

Safety Assessments

Description

Safety assessments include adverse events, vital sign measurements, physical examination findings, and clinical laboratory assessments.

Time Frame

3-hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-65 years, inclusive Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity Able to understand and comply with study procedures and requirements, and provide written informed consent Exclusion Criteria: Significant concomitant head, chest, or abdominal trauma Multiple extremity trauma Open fracture Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Indiana University

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trevena, Inc.

City

Indianapolis

State/Province

Indiana

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of TRV130 for the Treatment of Fracture Pain

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